DIOVAN HCT Drug Patent Profile
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When do Diovan Hct patents expire, and when can generic versions of Diovan Hct launch?
Diovan Hct is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for DIOVAN HCT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 49 |
| Patent Applications: | 219 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DIOVAN HCT |
| Drug Sales Revenues: | Drug sales revenues for DIOVAN HCT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIOVAN HCT |
| What excipients (inactive ingredients) are in DIOVAN HCT? | DIOVAN HCT excipients list |
| DailyMed Link: | DIOVAN HCT at DailyMed |
See drug prices for DIOVAN HCT
Recent Clinical Trials for DIOVAN HCT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ARKAY Therapeutics | Phase 1/Phase 2 |
| Albany Medical College | Phase 1/Phase 2 |
| LanZhou University | N/A |
Pharmacology for DIOVAN HCT
| Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for DIOVAN HCT
Paragraph IV (Patent) Challenges for DIOVAN HCT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DIOVAN HCT | Tablets | hydrochlorothiazide; valsartan | 320 mg/12.5 mg and 320 mg/25 mg | 020818 | 1 | 2007-02-07 |
| DIOVAN HCT | Tablets | hydrochlorothiazide; valsartan | 80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg | 020818 | 1 | 2005-12-02 |
US Patents and Regulatory Information for DIOVAN HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-001 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-003 | Jan 17, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-004 | Apr 28, 2006 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-005 | Apr 28, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DIOVAN HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-004 | Apr 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-001 | Mar 6, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-005 | Apr 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-004 | Apr 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-005 | Apr 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIOVAN HCT
See the table below for patents covering DIOVAN HCT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012051948 | SOLID ORAL DOSAGE FORM OF VALSARTAN | ⤷ Try a Trial |
| Germany | 19675036 | ⤷ Try a Trial | |
| Norway | 317181 | ⤷ Try a Trial | |
| South Africa | 9101179 | ⤷ Try a Trial | |
| Hungary | 0203374 | ⤷ Try a Trial | |
| New Zealand | 524346 | Solid oral dosage forms of valsartan | ⤷ Try a Trial |
| Russian Federation | 2453306 | ТВЕРДЫЕ ОРАЛЬНЫЕ ДОЗИРУЕМЫЕ ФОРМЫ НА ОСНОВЕ ВАЛЬСАРТАНА (SOLID ORAL DOSAGE FORMS OF VALSARTAN) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIOVAN HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0443983 | 97C0039 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 |
| 0443983 | 91676 | Luxembourg | ⤷ Try a Trial | 91676, EXPIRES: 20160212 |
| 0443983 | 23/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513 |
| 0443983 | 91347 | Luxembourg | ⤷ Try a Trial | 91347, EXPIRES: 20160212 |
| 0503785 | CA 2011 00026 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
| 0443983 | C300445 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| 0443983 | C980036 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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